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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Insufflator, Automatic Carbon-Dioxide For Endoscope
510(k) Number K881004
Device Name OLYMPUS-KEYMED ENDOSCOPIC CO2 REGULATOR, MODEL ECR
Applicant
KEYMED, INC.
KEYMED HOUSE, STOCK ROAD
SOUTHEND-ON-SEA
ESSEX SS2 5QH ENGLAND,  GB
Applicant Contact ROGER GRAY
Correspondent
KEYMED, INC.
KEYMED HOUSE, STOCK ROAD
SOUTHEND-ON-SEA
ESSEX SS2 5QH ENGLAND,  GB
Correspondent Contact ROGER GRAY
Regulation Number876.1500
Classification Product Code
FCX  
Date Received03/09/1988
Decision Date 05/12/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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